Phase 3
N=84
Liposomal Bupivacaine With Bupivacaine in Ankle Fracture Open Reduction Internal Fixation (ORIF)
Ankle Fracture
Bottom Line
View on ClinicalTrials.gov: NCT02480621 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Pain Levels on a Visual Analog Scale ( VAS) — 7.05; 4.03; 7.49; 6.60 units on a scale — p=<0.10
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Liposomal Bupivacaine with Bupivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jamaica Hospital Medical Center
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Levels on a Visual Analog Scale ( VAS) |
7.05; 4.03; 7.49; 6.60; 6.64; 5.22 | <0.10 |
Summary
This study is a randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively.
Eligibility Criteria
Inclusion Criteria
- Patients at least 18 years old.
- Male or Female
- All racial and ethnic groups
- Fractures and fracture/dislocations of the ankle
- Patients who opt for surgical treatment of their fractures.
- Patients who consent to be randomized.
- Patients who are willing to follow-up for a minimum of 52 weeks.
Exclusion Criteria
- Patients younger than 18 years old
- Patients who are on chronic opioids
- Patients who abuse opioids
- Patients who are unwilling to follow-up for a minimum of 52 weeks
- Neurologic condition that could interfere with pain sensation
Data sourced from ClinicalTrials.gov (NCT02480621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.